Senior Clinical Trial Manager to lead operational execution of post-market clinical studies, registries, and observational research programs supporting the LumiSystem platform. This role serves as the primary operational lead for study start-up, site activation, investigator engagement, clinical trial management, and cross-functional study execution.
Primary Responsibilities
Study leadership and clinical operations
- Serve as operational lead for post-market clinical studies, registries, observational studies, and clinical evidence generation programs.
- Develop and manage study timelines, milestones, risk mitigation plans, and site activation strategies.
- Lead study start-up activities from protocol finalization through first patient enrolled.
- Maintain oversight of study progress, enrollment, data quality, monitoring team, compliance, and operational performance metrics.
- Organize and lead recurring study team meetings and action item reviews.
- Collaborate with Clinical Affairs, Pharmacovigilance, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial Operations, and external study partners.
- Prepare study status updates for leadership, including enrollment forecasts, start-up metrics, action item status, and study risks.
- Lead issue escalations and facilitate resolution planning to maintain study momentum and alignment.
Site identification, feasibility, and selection
- Lead site outreach and recruitment activities for post-market studies.
- Lead and oversee site feasibility, qualification, and assessment processes, partnering with CRAs to ensure comprehensive evaluation of site capabilities, resources, recruitment potential, and operational readiness
Site start-up and activation
- Drive site selection, budget development, contract negotiation support, CTA/SOW execution, IRB readiness, regulatory document collection, and site readiness reviews.
- Track start-up performance and proactively remove barriers to activation.
- Coordinate site activation planning and study launch activities across multiple sites simultaneously.
Investigator and site relationship management
- Act as primary sponsor contact for participating clinical trial sites.
- Manage investigator communications and maintain strong collaborative relationships.
- Conduct study introduction meetings, start-up meetings, and operational discussions with site personnel.
- Support publication and research collaboration opportunities with participating investigators.
Site Initiation Visits and study training
- Lead planning, development, scheduling, and execution of Site Initiation Visits.
- Develop training materials, SIV presentations, agendas, and study-specific educational content.
- Coordinate cross-functional review and approval of study training materials.
- Present (or oversee presentation of) study procedures, data collection requirements, safety monitoring requirements, and operational workflows during SIVs.
- Ensure sites are fully trained and prepared for enrollment activation.
- Incorporate lessons learned from SIVs into future study operations and training materials.
Clinical monitoring oversight
- Partner with CRAs to ensure effective site monitoring activities.
- Review monitoring findings and support resolution of protocol deviations, data issues, and compliance concerns.
- Participate in development and maintenance of Clinical Monitoring Plans.
- Ensure appropriate oversight of study conduct and site performance.
- Provide timely responses to protocol, operational, and data collection questions.
Trial Master File and inspection readiness
- Maintain oversight of study TMF completeness and quality.
- Ensure essential study documents are filed throughout the study lifecycle.
- Coordinate TMF reviews, QC activities, closeout documentation, and inspection readiness activities.
- Support audit preparedness, inspection readiness initiatives, vendor transition documentation, and archiving activities as required.
Study documentation and operational materials
- Develop, review, and maintain study start-up packets, site activation materials, Clinical Monitoring Plans, study manuals, operational plans, training presentations, enrollment tracking tools, action item logs, and study status reports.
- Ensure study documentation is current, controlled, traceable, and compliant with applicable regulations and company procedures.
Vendor and CRO oversight
- Coordinate activities performed by CROs, contractors, and external service providers.
- Manage vendor deliverables and timelines, escalate risks, and track issue resolution.
Required Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Public Health, or related field.
- Bachelor's degree in Life Sciences, Nursing, Public Health, or related field.
- Bachelor's degree in Life Sciences, Nursing, Public Health, or related field.
- Strong knowledge of ICH-GCP, FDA regulations, clinical trial operations, post-market research, registry studies, and site management.
- Experience with study start-up, site activation, contracting, and IRB processes.
- Experience coordinating CRAs and cross-functional study teams.
- Excellent communication, organizational, and project management skills.
Preferred Qualifications:
- Advanced degree such as MPH, MS, RN, PharmD, or equivalent.
- Combination product experience or medical device experience.
- Oncology experience.
- Experience managing registries and post-market surveillance studies.
- Experience with EDC systems, eTMFs, and inspection readiness activities.
- Experience building study training materials and investigator-facing materials.
- Experience working in small-company or fast-paced clinical operations environments.
Critical Success Factors:
- Exceptional ownership and accountability
- Strong site engagement and investigator relationship management skills
- Excellent cross-functional leadership and follow-through
- Ability to convert clinical strategy into practical operational execution
- Ability to independently manage multiple studies and competing priorities
- Expertise in study start-up, activation, and site readiness
- Detail-oriented documentation practices
- Inspection-ready mindset
Senior Clinical Trial Manager will play a central role in generating high-quality post-market clinical evidence and supporting clinical adoption of the LumiSystem platform through collaborative, compliant, and inspection-ready study execution.
